Coronary Heart Disease (CHD) causes nearly 500,000 deaths per year and is the single leading cause of death in America today. Elevated serum cholesterol levels constitute a major modifiable risk factor for CHD, and the results of numerous large-scale clinical trials have convincingly demonstrated that lowering serum cholesterol reduces prevalence of fatal and non-fatal myocardial infarction as well as total mortality. The major ongoing public health effort to reduce coronary heart disease in the United States was sparked by the alarmingly high incidence of morbidity and mortality that resulted from this chronic disease. Because of this, there have been intensive efforts to develop new and more potent strategies to reduce risk factors for CHD. There are two major strategies for preventing CHD by lowering serum cholesterol. One is a patient based approach that seeks to identify individuals at high risk who will benefit from intensive intervention efforts. The goal of this approach is to detect, treat, and monitor high-risk individuals who have elevated serum cholesterol. The other strategy is the public health approach that attempts to lower serum cholesterol levels in the entire population by promoting changes in dietary habits and physical activity levels. These two strategies are complementary and both are incorporated in the National Cholesterol Education Program (NCEP) of the National Institutes of Health Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults updated recommendations for cholesterol management. This invention relates to the patient- based approach of identifying individuals at high risk for CHD.
Dietary intervention is the cornerstone of cholesterol lowering. Three major dietary factors contribute to high levels of serum cholesterol; these are a high intake of saturated fat, a high intake of dietary cholesterol, and an imbalance between calorie intake and energy expenditure leading to obesity. The NCEP has suggested the use of Step I and Step II Diet guidelines to assist the individual in modifying their diets. Step I and Step II Diets emphasize the choice of fruits, vegetables, grains, cereals, and legumes as well as poultry, fish, lean meats and low fat diary products instead of foods high in saturated fat and cholesterol, such as whole-milk dairy products and high-fat meats. The Step I and Step II Diets will be described later in the description. Thus, the primary aim of dietary intervention is to reduce CHD risk by decreasing intakes of saturated fat and cholesterol and by restoring appropriate calorie balance, while simultaneously promoting good nutrition.
Not all individuals are equally sensitive to dietary modification and some subjects will have high cholesterol levels that are inherently resistant to dietary modification. The mechanisms for this resistance are not completely understood. Because these individuals can not achieve the cholesterol-lowering goal despite good adherence to a Step I or Step II Diet, drug therapy may be the only effective treatment for their high serum cholesterol. For most subjects, at least 6 months of intensive dietary intervention and counseling should be carried out before considering drug therapy. Some subjects may even require 12 or more months of dietary intervention before considering drug treatment. This represents a delay in implementing an effective cholesterol-lowering regimen.
Thus, primary care physicians and their hypercholesterolemic patients lack a convenient, accurate, rapid and economic diagnostic method to determine how a person's serum cholesterol level will respond to the implementation of a cholesterol-lowering diet. A feature of the present invention is to provide such a diagnostic method.